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Matt McCoy: “Conflicts of Interest in Research: Disclosure is Not Enough"

Matt McCoy: “Conflicts of Interest in Research: Disclosure is Not Enough"

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On September 8, 2018, the New York Times and ProPublica reported that Jose Baselga, then chief medical officer at Memorial Sloan Kettering Cancer Center, had failed to disclose corporate financial ties in a number of scientific journals.1 The details of the story were striking. Since joining MSK in 2013, Dr. Baselga had received around $3.5 million from pharmaceutical and biotech companies and also served on the boards of six companies. Yet he failed to disclose any corporate ties in over 100 articles published during that period.

A week after the story was published, Baselga resigned from MSK. In his resignation letter, he accepted responsibility for “failing to make appropriate disclosures in scientific and medical journals and at professional meetings.”2 But he did not acknowledge anything wrong with a leader of an academic medical center having extensive financial ties to industry, including positions on corporate boards that required him “to assume a fiduciary responsibility to protect the interests of those companies.”1 Indeed, as he noted, his “involvement in a number of pharmaceutical and biotech companies” was reviewed by MSK and “the information was widely available to the public and members of the academic research community through a variety of sources.”2

Dr. Baselga expressed hope that the scrutiny he and MSK had received would “inspire a doubling down on transparency in our field” and spur efforts to standardize disclosure practices for scientific research.2 But if all that comes of this episode and the critical attention it has garnered is a renewed emphasis on disclosure, it will have been a missed opportunity. Instead of focusing narrowly on how researchers can do a better job of disclosing financial relationships with industry, we should take this opportunity to have a broader discussion about what sorts of industry-academic relationships are appropriate in the first place.

Over the last 25 years, as public funding for research has stagnated, drug, device, and biotechnology companies have funded an increasing proportion of biomedical research in the United States.3 During that time, partnerships between industry and academic researchers have been critical to the development of new drugs and medical devices. Yet academic medical centers and for-profit companies remain, as Arnold Relman put it, “quite different institutions, with largely different social functions.”4 The mission of drug, device, and biotechnology companies is to generate profits for shareholders and owners by bringing new products to market. The mission of academic medical centers is to provide excellent patient care, train physicians, and produce valid research—regardless of its consequences for the profitability of particular medical products. This is not to say that for-profit companies and academic medical centers cannot find common cause or engage in mutually beneficial partnerships, but it is to insist that for-profit companies and academic medical centers have fundamentally different goals.

These divergent goals create conflicts of interest for researchers with financial ties to industry—that is, circumstances in which their professional judgment may be distorted by their financial interests. These concerns are not merely hypothetical. There is a robust body of evidence suggesting that industry money has the potential to bias research. The most comprehensive systematic review to date of industry sponsorship and research outcomes concluded that “sponsorship of drug and device studies by the manufacturing company leads to more favorable efficacy results and conclusions than sponsorship by other sources.”5 And as a recent BMJ study found, researcher’s personal financial ties to industry also have the potential to bias research outcomes. The authors examined a cross section of randomized controlled trials (RCTs) published in “core clinical journals” and found that a personal financial tie between a principal investigator and the manufacturer of the study drug was significantly associated with a positive RCT outcome, even after controlling for the funding source of the study.6

The challenge for research institutions, and for individual researchers, is to determine how to capture the benefits of collaboration with industry while minimizing risks to research integrity. Simply pushing for more transparency around industry ties is an insufficient response. This is not to say that disclosure has no value or that, in the wake of the MSK controversy, we should not strengthen penalties for systematic failure to disclose significant financial conflicts, as some have suggested.7 As the National Academy of Medicine’s 2009 report on conflicts of interest pointed out, conflicts of interest cannot be addressed if they are not disclosed: “institutional officials cannot evaluate and respond to individuals’ relationships with industry if they are not aware of them.”8 But disclosure does not reduce the risk of bias. It is, as Marcia Angell says, “simply a way of saying caveat emptor, and leaving it to readers to decide whether the research was biased.”9

How should institutions and researchers themselves evaluate financial involvement with industry? Rather than trying to provide a single answer that is applicable to all types of involvement with industry, it is helpful to distinguish between types of involvement that have the potential to contribute to the aims of scientific research and those do not. Of course, there will be borderline cases, but this shouldn’t obscure the fact that there are also some easy cases. The clearest case of potentially beneficial industry involvement is sponsored research. Even among the most ardent “pharmaskeptics,” few believe that we should eliminate industry sponsored research, but institutions and researchers ought to implement and adhere to policies that limit sponsors’ power to affect study design and publication decisions. Implementing and enforcing these policies requires time and resources, to be sure, and reasonable people can disagree about how to calibrate polices to optimize the risk-benefit ratio of sponsored research.

But dealing with industry involvement that doesn’t contribute to the aims of scientific research is easier: it should be eliminated. As Howard Brody wrote, ‘“academic investigators need research funds to conduct studies, but do not need also to be paid fees as part of speakers’ bureaus, to become paid company consultants, to receive stock options, or to receive the various other rewards often granted to so-called “key opinion leaders.”’10 Similarly, leaders of academic medical centers do need to sit on corporate boards, though many do.11 There is, however, some indication that this trend might be changing. Four months after the New York Times and ProPublica published their story on Dr. Baselga, MSK announced that it would bar executives from serving on pharmaceutical company boards, and other institutions indicated that they might follow suit.12 This is a step in the right direction. Ultimately, the goal for researchers and institutions should be limiting rather than simply disclosing sources of potential bias.